Website Eurofins USA Clinical Diagnostics
Eurofins USA Clinical Diagnostics
Company : Eurofins USA Clinical Diagnostics
Job Description
The Quality Assurance (QA) Engineer will be responsible for bridging technical operations and quality assurance. Valuable in high throughput, regulated labs, and are key to preventing quality failures through proactive risk and process management. This role involves monitoring lab processes, conducting audits, analyzing data to identify potential issues, and driving continuous improvement initiatives to minimize errors and ensure data integrity.
Key Responsibilities & Duties
- Quality Management System (QMS): Participate in the maintenance and improvement of the QMS. Help ensure that procedures are compliance with regulatory standards (e.g. CLIA, CAP, FDA, ISO 15189). Identify and investigate non-conformances. Assist in developing technical SOPs and work instructions.
- Auditing and Compliance: Provide technical documentation for audits and inspections. Ensure all validation and qualification documentation is complete and audit ready. Plan and conduct internal audits of laboratory operations, processes, and systems to assess compliance with established quality standards and regulations. Support external audits and inspections from regulatory agencies.
- Corrective and Preventive Actions (CAPA): Conduct technical root cause analyses for system-related failures or deviations. Help develop and implement Action Plans.
- Process Improvement: Identify areas for process improvement and lead continuous improvement activities. Utilize Lean Six Sigma or other quality tools to identify inefficiencies. Develop and maintain process maps, value stream maps and other visual tools to identify bottlenecks and opportunities. Collaborate with lab operations and IT to improve workflows and reduce errors. Develop and use statistical analysis and quality control charts to monitor trends and recommend solutions for enhanced quality and efficiency. Assist in the development and refinement of quality metrics and dashboards.
- Training: Assist in the development and delivery of quality assurance training programs for laboratory staff to ensure adherence to quality protocols and procedures.
- Collaboration: Work closely with lab management, technical directors, and other cross-functional teams to integrate process improvements and quality requirements into daily operations and new process development. Contribute to the evolution of a proactive quality culture, aligned with our service vision and mission